BiondVax
A universal flu vaccine is the key to combating the ever-mutating flu virus, but did we ever really stop to think about whether there is a better way?
The flu virus, or influenza, is far more than a week-long inconvenience that pulls us away from our commitments, although that, in and of itself, is pretty annoying. The flu can get deadly fast.
According to the World Health Organization, influenza kills up to 650,000 people each year. Read that number again. In the US alone, the flu kills about 12,000 people in mild years, and up to 56,000 people in the more severe years, according to the Center for Disease Control.
Now we all know of the existence of the flu vaccine, but one of the reasons it needs to be taken annually is because the influenza virus mutates rapidly. As a result, the vaccines need to be updated to match the next season’s flu strains.
The influenza virus was first discovered in the 1930s, despite its having killed tens of millions of people in the pandemic of 1918. The vaccine was developed in the 1940s, but its effectiveness varies from year to year due to the mutating nature of the virus.
Although the vaccine’s rate of effectiveness is about 40% on average, it still saves lives and is still the best we’ve got.
The research and development of more effective flu vaccines is never-ending. The hassle of annually setting aside the time aside to obtain the vaccine becomes a bit much. This is where BiondVax comes in.
BiondVax is a publicly traded Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is a mixture of nine peptides, each containing no more than 22 amino acids (epitopes of HA, NP and M1 proteins of both Type-A and Type-B influenza viruses). In a nutshell, M-001 is designed to provide multi-season and multi-strain protection against all human influenza virus strains, both seasonal and pandemic.
BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In other words, if BiondVax succeeds at its mission, the flu vaccine is about to get a whole lot more effective and easier to apply.
IN A total of six completed Phase 1/2 and Phase 2 clinical trials covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic (produces an immune response). The ongoing pivotal Phase 3 clinical trial aims to assess the safety and effectiveness of M-001 in reducing flu illness and severity. We can all be hopeful about this because this is the only universal flu vaccine candidate in a Phase 3 trial. The results are expected to be announced by the end of 2020.
BiondVax was founded in 2003 by its CEO and president, Dr. Ron Babecoff. At the time, Babecoff was studying for an MBA in entrepreneurship and innovation in the Israeli branch of Swinburne University. It was during his coursework that he approached the Weizmann Institute of Science in Rehovot to look into their technology for use in a case study. This was what led to Babecoff meeting Prof. Ruth Arnon. Together, they developed the idea to bridge academia with industry and subsequently wrote a business plan.
In his third semester, Babecoff learned about capital markets and the basic structure of a company. Seeking to take the next step, he approached Isaac Devash – now a partner in a leading and life sciences VC fund, aMoon Partners – who helped raise BiondVax’s initial funds. The aMoon venture-capital firm works to advance cures for life-threatening diseases, as well as reduce major cost-drivers in healthcare by taking advantage of the growing convergence of healthcare with technology. I am personally a big fan of aMoon and many of its portfolio companies.
In 2005, BiondVax’s operations were up and running. Success followed quickly. The company was listed on the Tel Aviv Stock Exchange in 2007, and started trading on NASDAQ as BVXV in 2015.
Dr. Babecoff refers to the challenges and accomplishments of developing a universal flu vaccine using the “prime-boost approach.” This approach was initially a difficult sell for government agencies as it was new and unprecedented. However, agencies like the National Institutes of Health, which is funding and conducting a Phase 2 trial, saw its potential and promise, and the pace picked up from there.
BiondVax is presently a team of 20 people. In August of 2018, they moved out of their base near the Weizmann Institute in Ness Ziona to Hadassah Ein Kerem’s Jerusalem Biopark complex.
What’s next? They are currently scaling up the manufacturing process while running the clinical efficacy Phase 3 trial, which plans to enroll 12,000 participants.
By this time next year, BiondVax may be set to make medical history with the first M-001 universal flu vaccine. If they succeed, the rest of us can stop worrying about remembering to take flu shots every year.